DE19781097B4 - Blood and interstitial fluid sampling device for analysis=processing - uses lancing needle to pierce skin at rapid rate while ultrasonically kneading area to stimulate blood flow and pumping off sample - Google Patents

Abstract

A fluid sampling apparatus includes a housing member (1) which contains a lancing needle (16) used for piercing skin together with a spring member (11) for urging the needle to protrude form the housing end sufficient to penetrate the skin. A plunger (14) retracts the needle against the spring tension and a trigger member (2) engages the plunger to hold the needle retracted until released by the trigger. Stop and adjustment tabs (19) limit the depth of needle penetration of the skin and a sample container communicating with the needle receives the sample from the needle. Secondary springs retract the needle from the skin and a suction cam and plunger (22) activated upon retraction of the needle draws the sample of fluid which accumulates on the surface of the skin into the sample container.

Description

The The invention relates to devices and methods for obtaining Blood and other fluid samples from the body for analysis or processing.

Lots Medical procedures that are in use today require one relatively small blood sample, in the range of 5 to 50 μl. It is more cost effective and less traumatic for the patient, if one such a sample is obtained by having the skin in a selected location, z. On the finger, for taking one or two drops of blood pierced or pierced by being a veining specialist a tube venous Draws blood. With the emergence of domestic Self-examination, z. B. self-monitoring of blood sugar, the demand for a simple procedure is made, to be carried out at any place by a person who has to perform such a test can.

Conventionally used Lancets generally have a solid body and a sterile needle, which comes out of an end. The lancet can be used to pierce the skin, thereby calling a blood sample from the generated opening possible becomes. The blood gets into a test device or collecting device transferred. blood in most cases taken from the fingertips, where the blood supply in general is excellent. The nerve density in this area causes however, significant pain in many patients. A sample elsewhere, e.g. earlobe or limbs, will sometimes practiced to intervene in places that are less sensitive are. These sites are less likely to deliver blood samples and complicate the direct blood transfer on test devices.

Repeated Grooving in limited areas (eg lead fingertips for cornea formation. this leads to to greater difficulty in Blood drawing and stronger Pain.

Around the fear of piercing the skin and the associated To reduce pain, many spring-loaded devices have so far been developed. The following two patents are representative for the Devices used in the 1980s for use with home diagnostic test products were developed.

US Patent U.S. 4,503,856, Cornell et al., Describes a spring-loaded lancet injector. The reusable device can be fitted with a disposable lancet connect. The lancet holder can be locked in a retracted position. If the user has a trigger touched, causes a spring that the Lancet punctures the skin at high speed and up then withdraw. The speed is important to those associated with the puncture To reduce pain.

US Patent 4 517 978, Levin et al., Describes a blood sampling instrument. The device, which is also spring loaded, uses a standard disposable lancet. The construction allows a simple and accurate positioning on a fingertip, so that the Penetration point can be determined easily. After the lancet has pierced the skin, a return spring pulls the lancet in a safe position within the device back.

In appropriate facilities, it is often desirable to give the patient the sample take it off and then bring it controlled into a test device. Certain blood glucose monitoring systems require, for example, that the Blood test of a tester supplied that will come with a test instrument is in contact. In such situations, the direct contact the patient's finger with the tester a particular Risk of contamination with blood from a previous patient. In such systems esp. Re in health facilities It spreads a patient to sting the sample in a micropipette by capillary action and then remove them from the pipette Tester leave.

US Patent U.S. 4,920,977 to Haynes describes a lancet blood collection device and micro-collection tube. This device comprises a lancet and a collection container a single device. The stinging and losing weight are two separate activities, but the device is a convenient, single disposable unit for such cases where the decrease of the sample before use is desired. Similar devices are in Sarrine, U.S. Patent 4,350,016 and O'Brien, U.S. Patent 4,924,879.

US Patent 4,850,973 and 4,858,607, Jordan et al., Disclose a combined Device that is used alternately as a syringe injection device and as Lancing device with fixed disposable needle cellette can be used can, depending on the configuration.

US Patent 5 318 584, Lange et al., Describes a blood lancet device to withdraw blood for Diagnostic purposes. The invention uses a rotary / sliding motion transmission system to reduce the puncture pain. The penetration depth is simple and exactly adjustable by the user.

Suzuki et al., U.S. Patent 5,368,047, Domb rowski, U.S. Patent 4,654,513 and Ishibashi et al., U.S. Patent 5,320,607, all describe aspiration-based blood sampling devices. These devices develop a suction between the puncture site and the end of the device as the lancet retention mechanism retracts after piercing the skin. A flexible seal around the end of the device helps to close the end around the puncture site until a corresponding sample is pulled out of the puncture site or the user pulls on the device.

US Patent 4,637,403 to Garcia et al., And U.S. Patent 5,217,480 to Haber et al. disclose combined lancing and blood collection devices incorporating a Use membrane to create a vacuum over the wound.

The international application WO95 / 10223, Erickson et al a device for losing and measuring body fluids. This system uses a disposable lancing and suction device with a spacer that surrounds the skin around the lancet / needle zusemmendrückt.

unique Applicable devices are also suitable for one-time tests, d. H. home Cholesterol tests and designed for use in appropriate facilities been used to detect contamination between patients for many Exclude patients. Crossman et al., US Patent 4,869,249 and Swierczek, U.S. Patent 5,402,798, also disclose one-time usable disposable piercing devices.

Other devices for taking blood samples are described, for example, in US Pat. No. 3,741,197, Sanz, et al., DE-AS-1 938 870, Sanz, et al. FR 2 371 202 A Barthelemy, et al., And GB 2 294 641 A , Marshall, described.

In spite of The many improvements that have been made remain Pain associated with the stinging process is a significant problem for many Patients. The need for blood sampling and anxiety the associated pain is also a major obstacle for the Millions of diagnosed diabetics because of it associated pain does not monitor their blood sugar accordingly. Furthermore The stinging spreads to obtain a blood sample for others diagnostic applications are getting more and more, and it will be one less painful, minimally invasive device needed to use these applications to improve and make such technologies more acceptable.

A The object of the invention is an apparatus and a method to obtain a body fluid sample to provide through the skin that is virtually painless and minimal, is invasive. This object is achieved with the features of the independent claims.

A advantageous embodiment of the invention makes it possible to provide a procedural ren, the depending on the sampling point and applied penetration depth either leads to a blood or interstitial fluid sample. Although currently no commercial There are devices using interstitial fluid (ISF), are there any active efforts the correlation of substances to be analyzed, e.g. For example, blood sugar, in ISF compared to whole blood (whole blood). If ISF could easily be obtained and a correlation established ISF may be preferred as a sample since it does not interfere the red blood cells still a required hematocrit setting gives.

One Another advantage of the invention is that, as needed, a small, but adjustable sample, z. B. 3 ul at a test device and 8 μl at another test facility, can be pulled.

One Another advantage of the invention is that the drawn sample removed and can easily be presented to a testing device, independently from the location of the sampling site on the body. This method contributes to that for infection monitoring when, as here, not several patients with a single test instrument get in touch; only the sampling device with a disposable Patient contact part is created on the test instrument. As alternative can the disposable part of a tester be physically coupled to the sampling device so that the sample while the sampling is introduced directly into the test apparatus. The tester can then be read on demand in a test instrument, or the test system may be integrated into the sampling device and the test device can provide direct results that are displayed to the patient.

It is a further advantage of the invention that the device for the minimal invasive sampling with a reusable sampling device and a disposable sample receiving device can be.

In one aspect, the invention relates to a device that provides mechanical movement for piercing the skin and mechanical kneading or swinging to produce a fluid sample used from the body and can use a back pressure or vacuum to receive a small fluid sample into the device. In particular, the invention comprises a reusable sampling device and a reusable piercing / nibbling device. The apparatus may also utilize a back pressure, capillary action, or vacuum to receive a small fluid sample into the lancing / receiving device, which may later be deflated to dispense the collected sample to a testing device or other suitable vessel. However, the system may also be used to deliver the sample to an integrated disposable test device without taking up the body fluid sample and dispensing it separately.

One Process aspect of the invention is the piercing of the skin with fast speed (to reduce pain) with one Needle (the trauma and the pain reaction associated with pressure minimized, which occurs in a traditional lancet). The Skin is going through the puncture held tight to an accurate and repeatable To allow penetration of the needle into the skin. After drilling the skin, the needle is withdrawn from the wound and the surrounding area by ultrasonic action, piezoelectric or mechanical vibrations or squeeze roller kneaded to the bloodstream in the wound and stimulate out of it. In addition, heat, electrical Potential or friction can be used to stimulate additional body fluid flow. This fluid or blood stream may also be due to ultrasonic vibration of the Skin around the wound to be stimulated. In an alternative embodiment to stimulate blood flow, the needle remains for a period of time in the wound, either with slow mechanical vibration or Needle rotation, ultrasonic or piezoelectric vibration the needle to keep the wound open so the blood can collect. After the area has been stimulated and blood from the wound bulging, a capillary, syringe or pumping system is used, to draw microliter samples from the patient. A pull is on the needle or the suction tube created either by peristalsis, convection (application of Heat up a capillary tube) or through a small microsphere piston. The piston will retracted by spring action in the sampling device, wherein in the cylinder of the microsyringe, a vacuum is generated and the fluid quickly out of the body through the needle or suction tube is pulled into the piston to balance the pressure differential. The piston or suction device can then be turned over to to deliver the recorded sample. The system can also use a capillary tube which is used to pull the sample after it is up the skin surface has collected. The capillary tube can then send the sample to a desired Testing or Dispense analyzer by applying pressure through the tube or simply the end of the tube touched and the sample is touched with a surface or material, that has enough fluid retention capacity to expose the sample the tube to draw.

The above method and system can be on different parts of the body be applied. It is especially for use in other places suitable as the fingertips. Although fingertips a good one Providing bloodstream ensures the high density of pain receptors for one easy access to the blood, but also for very large pain during the sampling. With the method according to the invention a sample becomes active from the body the use of sampling sites on the body is possible, the for a traditional grooving are unsuitable. Because the procedure also a mechanism for the simple transfer of the Can provide sample, the difficulty of handing over the sample to a test device eliminated. An important advantage of this system is that through the use of alternative sites on the body reduces the accompanying pain sensation and more frequent use promoted as needed becomes.

While that Procedure can be easily applied to a blood sample In a minimally invasive way, an interstitial Fluid sample are also obtained, which generally one less deep puncture is used in places with lower blood flow. This becomes more important since exams which can use ISF samples that may be compared to Blood are preferred.

The The invention provides a stinging apparatus and method a patient and for virtually simultaneous generation and recording the Fluid sample ready, which are transferred to a tester can. A preferred device according to the invention has a blood collection system a piercing needle, a drive mechanism, kneading or vibrating mechanism and optional suction system and sample ejection mechanism. The device is preferably sized to be held in one hand and can be operated with one hand. The device can be optional integrated testing or analysis components for receiving the sample and providing it a test or Analysis display or output for contain the user.

The piercing and firing mechanism is capable of creating a wound which provides a corresponding sample, but which can also be fast closes and heals. The healing of the wound is a particularly important consideration for diabetic patients, who often have compromised circulatory systems and slow healing processes. The wound must have a geometry that provides a temporary space that can fill with blood, taking into account the elasticity of the skin tissue. Pay close attention to these geometries, otherwise the dermis will close around the piercing needle tip, and pulling a specimen through the tip will be ruled out. In a preferred embodiment, a needle is used in combination with a flexible cuff and an outer tube to widen the wound so that the blood can collect. Alternatively, a multiple needle piercing device can be used to create a wound that pierces multiple capillary areas to quickly provide a large sample size, but the smaller multiple wounds are easier to heal.

In an alternative embodiment the needle / lancet is withdrawn from the wound, and the area which surrounds the wound is massaged or stimulated to prevent that she closes, and to the body fluid and / or to promote blood flow to the wound and surface of the skin.

Devices according to the invention create a lancing movement, which in the small, but numerous Capillaries of the surface vessel network cuts under the epidermis. The vascular area begins in many accessible Areas all over (Forearm, thigh, abdomen, palm) at a depth of 0.3 to 0.6 mm from the surface of the Skin. Blood is abundantly supplied to this area of the skin, and the healing of small wounds is not problematic. But one correspondingly large Drop of blood on the surface to bring is more problematic than with a finger pen. A Fingertip is usually massaged to a momentary bloodstream to increase. The invention provides a system for mechanically massaging a Puncture site on other parts of the body by several different methods, including swinging an annular Around the wound, around the wound around the wound Extraction by a needle or the capillary tube or the vibrating wings or other parts adjacent to the wound to pump into the wound the wished To reach the bloodstream. Furthermore, it is very difficult at others Areas of the body, z. B. on the thigh, a drop of blood from the skin to a small area on a tester too bring. An alternative according to the invention embodiment works in such a way that the Needle remains in the wound and is mechanically manipulated to the training of a body fluid sample to promote in the wound.

The Needle can be in a desired and effective vibration movement, including one Up and down movement, a lateral movement, a circular movement, a rotary motion or any combination thereof. It arises a momentary opening, that fill with blood can, while the device draws blood through the needle into the disposable sample receiving chamber draws. The vibration of the needle can be done in a wide range, from 30 cycles per minute up to 1000 cycles per minute or more. This low vibration increases the perception by the Patient not measurable, especially if it is of short duration, but increases the sample volume, that can be easily pulled out of a given wound, and the Speed at which the sample volume originated from the wound becomes clear. The vibration can cause the needle to stretch up to 2 to 3 mm per oscillation moves. The optimal needle vibration is less than 1.5 mm, according to current studies about 0.5 mm are preferred. By swinging or turning the needle with 30 to 1000 oscillations or rotations per minute and more the wound is kept open, and it prevents them from becoming includes and stopping the sample, and picking up the sample can be in a shorter time Time.

The Grooving is conventionally done in an angle of 90 ° (vertical) to the skin surface. However, we have found that the lancing piece significantly more Capillaries puncture if the puncture is made at an angle. At too low an angle, there is no significant penetration reached. The piercing with an angle of incidence of 15 to 90 ° to the surface of Skin is effective, with shallower angles involving a larger bloodstream produce.

The inventive device and the system of the invention can further increase the bloodstream, by massaging the area before piercing and by the The area adjacent to the puncture site is massaged while the lancing part in the wound and after it has been removed from the wound, as well as during the sample holder as described above. Alternative procedure can a streak or Use wiper device to over to stroke or vibrate the skin, or can the skin heat respectively, to increase the blood flow to the sampling site.

In a further alternative configuration, the piercing needle may be withdrawn very little from the point of maximum penetration to create an opening in which blood may collect before being aspirated through the device. This can be done with a double-stop system that locks the needle at maximum penetration then retracting the needle after a partial but not complete retraction. The area around the wound can be kneaded or massaged by optional moving parts to stimulate blood flow to the wound and increase the sample size and rate of sample production. The mechanical movement can shift the area around the wound from 0.05 to 8 mm, with 1 to 5 mm being preferred according to current studies. A scraping or wiping device may be used from the point of being stroked over the skin to increase blood flow to the wound by stimulating the capillaries.

The Mechanical stimulation of the wound can be done using different methods or movements and parts. A circular ring or other polygon or leaf or wing parts can um the wound around by piezoelectricity, ultrasound, electromagnet / coil, Motor and eccentric or other methods known to those skilled in the art, be vibrated. Mechanical vibration in the area from 2 to 1000 vibrations per minute are possible, with 10 to 400 vibrations to be favoured. Ultrasonic vibration is at a frequency of after all, 40 kHz has been effective. As an alternative, the device a leaf or squeeze roller stimulator use the spot with horizontal motion or a combination from horizontal and vertical motion kneads and the bloodstream promotes to the wound. The squeegee can apply to the wound area 2 to 200 times per minute act according to current Investigations 60 times per minute is preferred. In addition, can the needle is vibrated ultrasonically, with or without kneading or massage movement near the wound. The ultrasonic vibration can in the ultrasonic frequency range, depending on the sampling area and whether the needle or stimulation device is activated.

Under In another aspect of the invention, the lancing member is disposable Multi-chamber or Mehrkanalkapillarteil included, wherein a chamber contains the lancing part and an adjacent chamber is suitable for the blood or fluid emerges from the wound to record. The disposable multi-chamber capillary part may be made of any suitable material and in a sampling device be installed so that it is positioned in a suitable position relative to the wound, the is generated to receive the sample. The lancing device is driven into the skin and from the return springs after reaching the attacks withdrawn. After retreating of the lancing part becomes the stimulator ring or another polygonal one Shape vibrated by one of several methods, to pump blood from the capillaries near the wound. The sampling device according to this Aspect of the invention has stop mechanisms to prevent the intrusion of the Limit lancing part, and a sampling duration system, which sets the time of taking the sample. The lancing part guiding chamber can be trained in many different ways, and the One skilled in the art can redesign these to alternative embodiments to create.

Under similar to another aspect As described above, the lancing member may be contained in a single capillary tube and be able to extend from the end of the tube to the wound to create. The lance then pulls to a sufficient Stretch back within the capillary to allow the desired sample at the end of the same capillary tube in the room under the withdrawn Lancing piece can be added. In such an embodiment For example, the lancing member in the wound may be vibrated prior to retraction be, as described above.

To achieve picking up of the sample after retraction of the needle, a stimulator ring may be used to pump the sample through the wound opening from the surrounding capillaries. The stimulator ring is capable of keeping the skin taut to allow for better penetration of the skin during grooving and to help keep the wound open during pumping. It may be appropriately vibrated to ensure that a sufficient sample is pumped from the local capillaries. The time or number of oscillations depends on the person or place where the sample is taken. To achieve a variable sampling time, one of the following methods can be used. A sensor may be incorporated in the sampling device which detects the blood in the receiving chamber or device. When a sufficient sample level (which can be adjustable) is reached, the pacing mechanism is turned off. A second method is to use a patient-definable input that determines the duration of the test and the number of vibrations for the stimulation ring. Additional stimulator movements can be used to promote the extraction of body fluids. These include sinus motion, swinging, kneading or peristaltic motion. An alternative stimulator device may be implemented with an inner or outer ring that alternately generates a peristaltic pumping motion on the capillaries around the wound. Another alternative stimulator device uses a coil spring that can be flattened to multiple Simulating pumping rings. As will be seen, various configurations of multiple stimulator rings, wing or other parts applied in different rhythms or sequences of motion may be used in the invention. The stimulator ring or stimulator portion may be heated to heat the skin to increase the capillary volume flow to and from the wound. In addition, the housing or casing of the device or other components of the device may be heated to heat the skin.

Under In another aspect of the invention, a diffuse laser may be used become the surface vessel network to penetrate, and a capillary tube can be used to take the sample. A lens can be used to fix the To make the laser diffuse, so that he not big Wound produced or big Damaged skin or tissue areas. A minimal wound size is important to facilitate a quick healing. The Recording capillary tube may use a suction generator to pull up the sample in the tube, and may also use an optional stimulator ring to do this To pump blood from the adjacent capillary vats.

Under In another aspect of the invention, the piercing by a Pulse of a fluid under high pressure, z. B. a liquid or a compressed gas. In addition, the compressed Gas at lower pressure to be directed to the skin surface to the Skin before grooving while grooving and / or during to massage the sample. By dispensing compressed gas pulses on the skin when desired To press, Profiles and intervals, including a sequence profile over the surface of the Skin, the desired stimulation of the bloodstream to the wound and out of it. The compressed gas pulse used to puncture and open the To perform a wound, may be a single pulse or multiple pulses, may be directed through a sample-receiving capillary tube and / or may be applied vertically to the surface of the skin or at an angle be as above for other latches described to a piercing possible To reach many capillaries in the skin and the absorption of the to achieve a sample in a very short period of time.

Under Another aspect is a test device independent of a measuring device with a sampling device according to the invention used an integrated sampling and testing device provide. The device can be used by the patient to draw a sample and these at substantially the same time the presence or concentration of an analyte Substance in a body fluid too check. The sample can with the inventive device of another Place to be taken as the fingertips. To do this is it is critical for the exam, when a mechanism is provided to the wound and / or the surrounding area to stimulate a corresponding sample for the testing device. The stimulation can be performed by manipulating the needle or skin area around the wound becomes as described above. A combination of the two methods can be used to increase the volume and / or the sampling time to reduce. The sample is sent directly to the test device or test area introduced and not recorded and then submitted.

Under Another aspect is a method for determining sample size before handover and exam provided. Various methods can be used to accomplish this Volume and / or the presence of the sample to capture. A system uses two contacts to indicate the presence and / or volume to capture a sample. The body fluid is either in a tube after pulled up or swells from the surface of the skin where it is a short circuit between two Generates contacts that signal that the right sample has been pulled has been. An alternative system uses an LED and a receptacle. If the sample rises to a level where it separates the LED from the receiver, the right sample has been drawn. Other optically activated or contact-activated systems be used in this aspect of the invention.

Under In a further aspect, a method for producing a Unit with a disposable part ready to take a health To limit risks of cross-contamination.

Under In another aspect, a bell-shaped capillary tube is provided posed. The capillary tube pulls the sample in the tube up, until the transition has reached the ball or to the balloon. The balloon is then pressed to the sample or a known volume of the sample at a desired Place, z. B. on a test strip or a testing device, for analysis. The bell shape can be designed as a cone, and the sample can pulled up in the cone and released by the cone turned over and the sample is released by capillary action on the tester becomes.

In an alternative embodiment, the invention Vorrich pierces and stimulates tion the area, wherein a fluid sample drop is generated, which is taken directly into or transferred to a tester by the tester is applied to the droplets.

Under In another aspect, the device may also include an automatic injection device. A previously charged head can be inserted into the cylinder. The trigger and spring system can run like this be that the Sample is dispensed from the syringe rather than a sample in the syringe To pick up a syringe. One skilled in the art could easily describe the one described Reshape mechanism to still inject a sample. In addition, can the device has a dual function of receiving a sample, while simultaneously or sequentially, a sample is injected, which as Answer to a test can be done in the device with the recorded sample carried out has been.

Summary the drawings

1 shows a device according to the invention with a double stop mechanism.

2A and 2 B are sectional views of a device according to the invention in the cocked or extended position.

3 shows a longitudinal section of a device according to the invention with a stimulator part near the lancet or needle.

4 shows a stimulator part positioned on the skin of the patient near the wound and the lancet.

4A Figure 11 is a schematic representation of the skin showing where the capillaries of the surface vessel plexus are relative to the skin surface.

4B Figure 3 is a sectional view of a wound facilitating the formation of a small blood collection site, but ensuring that the skin contracts completely after sampling around the wound to promote healing. The relationship between the wound, the needle and the capillaries of the surface vessel network is also shown. In the illustrated embodiment, the capillary is displaced in the needle.

4C and 4D show alternative embodiments in which the needle is mechanically vibrated, either in an up and down motion as in FIG. 3, to improve the picking up of the sample and to minimize the wound size 4C shown, or in a transverse movement, as in 4D shown.

4E shows that the needle can be vibrated with or without kneading or massage movement in ultrasonic vibration.

4F and 4G show that the area around the wound can be kneaded by an optional mechanical motion to stimulate blood flow to the wound and to increase the sample size and the rate at which the sample is produced.

4H shows that the device may alternatively use a squeegee stimulator which kneads the site with a horizontal movement or a combination of horizontal and vertical movement and promotes blood flow to the wound.

4I shows an alternative embodiment in which a needle is set in vibration or rotary motion.

5A and 5B show a front and a side view of a replaceable needle with a spur point design, which is suitable for use according to the invention, in particular for a movable / rotatable needle for holding open a wound during the sample receiving.

6A and 6B show a front and a side view of a disposable needle having an eccentric passage for sample receiving. The needle may have a luer locking connection with the sampling device according to the invention.

7 shows a needle with a cuff or sleeve to allow mechanical spreading of the wound during sampling.

8A and 8B Figure 12 is a longitudinal sectional view of the multi-chamber capillary device receiving a lancet or needle in one chamber and providing another chamber or tube for sample collection.

8C . 8D and 8E are sectional plan views of two- and three-chamber capillary parts.

9A and 9B show a longitudinal section of a device with a disposable and peristaltic multi-chamber capillary pump to receive a sample.

9C shows an alternative on average disposable suction / spacer / lancet head with contacts for electrically sensing the presence and / or volume of body fluid.

10 shows in section a device with a laser positioned to radiate through the interior of the needle or capillary for piercing the skin.

11 shows in longitudinal section a device according to the invention for use with a combined suction / spacer chamber as part of a disposable sampling system.

12A and 12B show a longitudinal and a side section of a device according to the invention, which has an angular lancet or needle and uses an absorbent strip.

13 and 14 show a longitudinal and a side section of a sampling device according to the invention with an integrated colorimetric instrument test.

15 shows a longitudinal section of a sampling device according to the invention with an integrated electrochemical test.

16 and 17 show a longitudinal and side section of a sampling device according to the invention with an integrated colorimetric visual inspection.

18 Figure 4 shows an alternative device having a fully disposable lower part to minimize blood contamination between applications.

19A shows an alternating double stimulation ring system combination.

19B shows the device with a telescoping stimulator ring.

20A . 20B and 20C show a bell-shaped capillary tube, and

20D shows a straight capillary tube with a test strip.

21 shows a device according to the invention with a part to vibrate the needle to stimulate the fluid flow from the wound.

22A shows a multiple needle piercing system.

22B shows a wider single lancet.

22C and 22D show a stamped platelet having a number of small barbs on the platelet for use as a lancet according to the invention.

description the invention

1 shows a minimally invasive sampling device according to the invention. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical components housed in the device.

The main body 1 has an elongated hollow cylindrical tube with openings at both ends. The sampling needle 16 that part of the disposable 3 is that can be withdrawn and extended so that it over the needle guard 17 stands out, is positioned at one end. The tensioning and dispensing piston 22 sticks out of the other end. The device has a needle guard 17 that loading the disposable device 3 allows. The disposable device 3 is at the syringe 13 attached, and the piston 14 is through the suction cam 8th Approved.

The syringe 13 is by means of a syringe clamping device 12 , with the main connecting rods 4 anchored, captively attached to the drive system. The main drive springs 11 are between the syringe clamp 12 and a cross-brace 10 firmly arranged, and the connecting rods 4 are passed through them.

At the main connecting bars 4 are the main cams 9 attached and released from the activation trigger prior to their release 2 supported. The auxiliary springs 21 and the auxiliary stops 20 After activation, provide a mechanism to pull the needle back out of the wound to allow for blood accumulation. When the skin is pierced, pull the auxiliary springs 20 the needle back out of the wound, with the suction cam 8th pushed and the piston 14 is released. The tensioning and dispensing piston 22 is a device with dual purpose. When the patient pulls it up, it becomes the mainspring 11 preloaded. He is locked by clicking on the activation trigger 2 is pressed.

The stop and adjustment devices 19 control the penetration depth of the needle 16 so that the optimum penetration depth for a particular sampling point is achieved. The sample 15 is pulled out of the patient after the device by releasing the activation trigger 2 extended and the needle 16 has been withdrawn from the patient.

This in 2A and 2 B shown system consists of a reusable cylinder 1 and associated mechanisms and a sterile disposable device 13 , The disposable device 13 has a needle 16 with a very fine inner diameter embedded in a cap until the device is prepared for use. 2 B shows the device in the extended state with a sample in the disposable 13 , and 2A shows her in the retracted state.

A main yoke 3 is activated by activation 2 kept the main connecting rods 4 support when the system is retracted. The system is activated by the activation triggers 2 be solved. This will be the main cam 9 solved, which causes the syringe by the mainspring 11 is extended, which is between the cross brace 10 and the syringe clamps 12 is held. The needle 16 pierces the skin as a result of these operations, and the penetration depth is from the stop 27 controlled. When the suction cams 8th from the auxiliary release 5 released, the suction spring 6 Approved. This will make the suction yoke 7 due to the damping effect of the syringe plunger 14 slowly moved upward, so that in the syringe body, a back pressure or vacuum is formed. The sample 15 is actively drawn into the syringe.

The sample can be easily and accurately dispensed to a sampler or other container by pressing a button on the sampler. The disposable syringe 13 and the needle 16 may remain embedded in the cap in which they were shipped, or may be placed in a Sharp container for safe disposal.

To ensure that a sufficient sample size has been recorded, the needle can 16 be placed in vibration, vibration or rotational motion to prevent the wound from closing. The revelations in 3 . 4 . 4C . 4D . 4E . 4I . 9 . 12 and 13 show and describe various alternative movements that can be used to accomplish this.

A Another version of this device is also able to be used as an automatic injection device work. A preloaded head can be inserted into the cylinder become. The triggering and spring system can run like this be that the Sample is dispensed from the syringe instead of taking a sample. A specialist could readily reshape the mechanism described yet to inject a sample.

3 shows a minimally invasive sampling device according to the invention. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical components housed in the device.

The main body 1 has an elongated hollow cylindrical tube with openings at both ends. The sampling needle 16 that part of the disposable 3 is that can be withdrawn or extended so that it over the needle guard 17 can stand out, is positioned at one end. The tensioning and dispensing piston 22 sticks out of the other end. The device has a needle guard 17 that of the patient in the main body 1 can be moved up and down to the loading of the disposable device 3 to enable. The disposable device 3 is with a head adapter 18 at the syringe 13 attached. The internal parts of the syringe 13 are the piston 14 that of the suction spring 6 is activated, and the suction yoke 7 , The piston is released when the suction cam 8th from the auxiliary release 5 is released.

The syringe 13 is means of a syringe clamping device 12 , with the main connecting rods 4 anchored firmly attached to the drive system. The main drive springs 11 be between the syringe clamp 12 and the cross brace 10 captively fastened, and the connecting rods 4 are passed through them.

At the main connecting bars 4 are the main cams 9 attached and released from the activation trigger prior to their release 2A supported. The auxiliary springs 21 and the auxiliary stops 20 After activation, provide a mechanism to pull the needle back out of the wound to allow for blood accumulation. When the skin is pierced, the auxiliary springs pull the needle out of the wound and release the vibrating system 26 and 27 of the stimulation ring 25 to force a bloodstream to the wound. The tensioning and dispensing piston 22 is a device with dual purpose. When the patient pulls it up, it becomes the mainspring 11 preloaded. He is locked by clicking on the activation trigger 2A is pressed.

The stop adjustment devices 19 control the penetration depth of the needle 16 so that the optimum penetration depth for a particular sampling point is achieved. The stimulator ring may be deployed during grooving to keep the skin firm, allowing a more accurate and repeatable penetration of the skin. The sample 15 is pulled out of the patient after the device by releasing the activation trigger 2 extended and the needle 16 has been withdrawn from the patient.

4 shows the relationship between the needle 16 , the wound 200 and the stimulation ring 25 , The details of the skin are shown for clarity. The stimulator ring 25 is used to sample the body fluid 61 in the wound area 200 to pump. In this illustration is a single stimulation ring 25 shown. However, multiple telescoping rings can be used to enhance blood transport.

The stimulation ring may also be formed with a series of notches to allow the return of body fluid into the capillaries when the stimulation ring 25 from the wound 200 is withdrawn.

In an alternative embodiment, the stimulation ring is heated or, in addition, auxiliary motion occurs to act as a wiper or wiper device to direct body fluid flow to the wound 200 to improve. Other parts may be used instead of a ring to achieve the desired stimulation.

4C . 4D and 4E show that the needle can be put into the desired vibratory motion. This creates a momentary orifice that can fill with blood as the device draws blood through the needle into the disposable sample receiving chamber. The vibration of Na del can be done over a wide range, from 30 to 1000 cycles per minute or more. This low vibration does not measurably increase the patient's perception but significantly increases the sample volume that can be easily drawn from a given wound and the rate at which the sample volume is produced from the wound. The vibration can cause the needle to move up to 2 to 3 mm per oscillation. The optimum needle vibration is less than 1.5 mm, with about 0.5 mm being preferred according to current studies. The piercing is generally at an angle of 90 ° (perpendicular) to the skin surface. However, the lancing member can pierce significantly more capillaries when the puncture is made at an angle. At a very shallow angle, no significant penetration depth is achieved. Piercing at an angle of incidence of 15 to 90 degrees to the surface of the skin is effective, with shallower angles producing greater blood flow. The ultrasonic vibration may be in the ultrasonic frequency range, depending on the sampling area and whether the needle or the stimulation device is activated.

4F and 4G show the massaging or kneading of the area around the wound. The mechanical movement can shift the area around the wound from 0.05 to 8 mm, with 1 to 5 mm being preferred according to current studies. 4G shows a scraping or wiping device that sweeps across the skin to increase blood flow to the wound by stimulating the capillaries. This procedure may also be performed by the patient by stroking over the area to increase blood flow to the sampling site prior to sampling. The vibration may be by piezoelectricity, ultrasound or by using a solenoid / coil or a motor and cam. Mechanical vibration can be in the range of 2 to 1000 vibrations per minute, with 20 to 200 vibrations being preferred. Ultrasonic vibration has been effective with a frequency of at least 40 kHz. 4F shows an alternative embodiment in which the wound is mechanically stimulated, z. B. by a circular ring that can be set in vibration.

4H shows massaging with a squeeze roller stimulator. Such a nip roll may act on the wound area 2 to 200 times per minute, with 60 times per minute being preferred.

4I shows the spinning or swinging of the needle from 30 to 1000 cycles per minute or more. This keeps the wound open and prevents it from closing and interrupting sample collection. This embodiment can use needles which are shown in FIG 4B . 5A . 5B . 6A and 6B conventional needles or round or flat lancets.

5A and 5B show a spur needle / lancet profile used in the invention to create a void area in the wound. 5A and 5B show a needle profile that is useful in the implementation of this embodiment. The spur end helps to create a void area when rotated in the small wound.

6A and 6B show an asymmetric needle design to create a wound that improves capillary blood uptake. The needle 16 is as a disposable device 3 educated. Another aspect of the invention is the presence of an easily exchangeable piercing head ( 6A and 6B ). The head must be easily attached to the device to provide a fresh, sterile needle for each sample drawn. A wide range of lancet or needle sizes can be used for the head. Current studies indicate that 10 to 32 sizes are acceptable depending on the sampling site. The entire device can also be designed as a device which can be used once. In this configuration, the device would be biased and would trip and dispense only once. It would be so For each sample drawn a new device with a sterile head can be used. It will be appreciated that an alternative disposable device may be constructed of a needle and a flexible tube. The tube acts as a reservoir for the sample when pulled through an applied vacuum. Another capillary disposable device is in 20A shown. The bell-type disposable utilizes the capillary action to pull the sample up the tube until it reaches the piston, or the vacuum created by pushing the balloon. The sample is dispensed by squeezing the balloon. One skilled in the art could readily redesign the embodiment shown here as a one-time-use device.

7 shows the use of a needle 16 with a flexible cuff 225 and a stimulator ring 25 which are intended to keep the wound open during the extraction of the body fluid sample. The cuff 225 is attached to the needle and acts as a stop and device for spreading the wound. This provides a means to force the wound to remain open during sampling. The cuff 225 can be implemented in various configurations, the same results being achieved by the person skilled in the art.

8A shows that the lancing part is part of a capillary multi-chamber disposable device. 8B is an exploded view of the end of the device showing the relationship between lancet 30 , Disposable device 33 and lancet guide tube 35 shows. The capillary multi-chamber disposable device may be made of any suitable material. 8C . 8D and 8E show various alternatives of this embodiment. One skilled in the art could readily redesign a disposable device that would conform to this invention.

The lancet 30 creates the wound and is passed through a guide tube 35 guided. The sample is placed in the sample pick-up tube / disposable 33 pulled up. The complete device may be implemented either as a single disposable device or as multiple components.

9A shows an inventive, minimally invasive sampling device, the alternative disposable capillary blood collection device in 8A used a disposable device 33 is. The device consists of numerous components, which are described more fully below. The main body 1 carries the various mechanical components housed in the device. 9B shows the section that allows access of the blood to the sample tube.

The main body 1 has an elongated hollow cylindrical tube with openings at both ends. The disposable capillary sampling device with a lancing piece 30 , the part of the disposable device 33 is and can be withdrawn or extended, leaving it over the end of the main body 1 can protrude is positioned at one end. The tensioning piston arrangement 36 sticks out of the other end. The lancing piece 30 is protected by placing it in the needle guide tube 35 being withdrawn, the part of the disposable device 33 is. The needle guide tube 35 acts as a lancing guide and lancet protection. The disposable device 33 gets on the main body 1 attached so that it is positioned in the appropriate place to guide the lancet and to suck the blood upwards. The firing pin 39 is pushed forward to the lancet in the patient 41 to drive, by the spring 43 and the tensioning piston assembly 36 , The tensioning piston is in its normal position by a cam 45 and triggers 47 locked. A double stop return spring 49 is arranged and dimensioned to the lancet 30 back in the disposable 33 the needle guide tube 35 retrieve. With the needle guard 17 lies the main body 1 on the patient 41 on.

The double-stop return springs 49 After activation, they provide a mechanism to pull the needle out of the wound to collect blood 61 to enable. When the skin is pierced, pull the auxiliary springs 49 withdraw the needle from the wound and release the vibratory system of the stimulation ring 25 to force a bloodstream to the wound. The stimulator ring can oscillate in the preferred range of 1 to 5 mm. The frequency may vary from 5 to 1000 oscillations per minute in the preferred embodiment. The vibration of the stimulator ring 25 is through the coils 51 stimulated the stimulator ring 25 vibrate to pump blood from the surrounding capillaries in the skin into the wound. Every downward stroke of the stimulator ring 25 causes this pumping process. This pumping action can be modified to include sinusoidal, vibratory, kneading or peristaltic motion that increases blood flow to the wound.

A connecting link 53 Moves a peristaltic roller system 55 and roles 57 against the suction tube 59 , which causes blood 61 in the suction tube 59 is pulled up to the sample 15 to create.

The stop and adjustment devices 19 control the penetration depth of the lancet 30 so that the optimum penetration depth for a given Probenent is reached.

In another aspect of the invention, an electrical potential may be applied across the skin to also stimulate blood flow to the wound. This can be done by having separate electrodes in the device to contact the skin and deliver the electrical current at desired locations. Or the current can be delivered to the skin via components of the device that are naturally sufficiently isolated inside, e.g. B. the stimulator ring 25 and the sample tube 59 or any other suitable combination. In general, a low voltage DC or AC current can support the blood flow. The voltage, current and oscillations (in the case of alternating current) can be determined by a person skilled in the art, but DC voltage is suitable in the range from 1 mV to 12 V. Likewise, the duration of the supplied current or its pulses can be determined as needed. In a specific example, the tube may 33 in 9A or the needle 16 in 3 the negative electrode and the ring 25 in 9A and 3 or the protection 17 be the positive electrode.

9C shows an alternative suction / distention chamber blood collection device 72 holding a lancet 30 , a suction tube 59 , an auxiliary tube that holds the lancet 30 leads, a suction / Distanzhaltekammer 105 and contacts 107 and 109 having. The suction tube 59 is in the suction / spacer chamber 105 arranged so that the suction tube can be located away from the wound to promote bleeding while the wound is stimulated. The contacts provide a means of determining if the sample size is sufficient. The contacts 109 Be closed when there is sufficient blood volume in the cap 105 is present, and these are related to the contacts 107 in communication with the electronic package of the sampling device. If the contacts 109 are closed by the blood, then the circuit is closed and signals that the system should stop.

10 shows a minimally invasive sampling device according to the invention, the alternative disposable capillary blood collection device and a piercing mechanism with a laser 67 used. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical components housed in the device.

The main body 1 consists of an elongated, hollow, cylindrical tube with openings at both ends. The capillary disposable disposable device with a diverging lens part 60 , the part of the disposable device 63 is in one end of the main body 1 Installed. The firing switch 65 sticks out of the other end. The capillary tube 59 acts as the laser guide and the sample receiving device. The disposable device 33 is at the main body 1 attached so that it is positioned in the right place to direct the laser and to suck the blood upwards. The laser 67 is dissipated as it passes through the lens and creates the wound in the patient.

When the skin is pierced, the laser shuts off. This turns the vibration system of the stimulation ring 25 triggered to force a bloodstream to the wound. The vibration of the stimulator ring 25 is through the coils 51 stimulated the stimulator ring 25 set in motion the blood 61 from the surrounding capillaries in the skin to pump into the wound. Every downward stroke of the stimulator ring 25 causes this pumping process. A connecting link 53 moves a peristaltic role system 55 and roles 57 against the suction tube 59 for that blood 61 in the suction tube 59 can be pulled upwards, taking the sample 15 arises. The vibration of the stimulator ring may be in a range of 0 to 8 mm, and preferably 1 to 5 mm. The frequency can also vary from 2 to 100 oscillations per minute.

In an alternative embodiment of the device according to 10 For example, the piercing means may be a high pressure liquid or a pressurized gas pulse instead of the laser. One or more compressed gas pulses may be directed to the skin. In addition, the pressurized fluid or gas pressure pulses in the annular space between ring 25 and housing 1 used to massage and stimulate the skin to increase blood flow to the wound.

It is understood that the vacuum used in various embodiments of the invention can be used with the capillary tubes, e.g. B. 59 in 10 , as well as with the needles in 4B . 5A and B and 6A and B ,

11 shows an inventive, minimally invasive sampling device, the alternative suction / spacer chamber blood collection device 72 used by the illustration 9C more fully described. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical components housed in the device.

The main body 1 consists of an elongated, hollow, cylindrical tube with openings at both ends. The suction / spacer chamber sampling-disposing device with the lancing member 30 , the part of the disposable device 72 is and can be withdrawn or extended, leaving it over the end of the main body 1 can protrude can be positioned at one end. The clamping devices / triggers 37 protrude from the sides of the main body 1 out. The disposable device 72 gets on the main body 1 attached so that it is positioned in the right place to guide the lancet and suck the blood upwards. The firing pin 39 is pushed forward to the lancet in the patient 41 to drive, by the spring 43 and the tensioning piston assembly 37 , The tensioning piston is in its normal position by a cam 45 and a trigger 37 locked. A double stop return spring 49 is arranged and dimensioned to the lancet 30 retrieve.

In a further aspect, the capillary sample pick-up tubes used in various embodiments of the invention, e.g. B. 33 in 8A and 9A . 59 in 9C and 10 and 150 in 20A to 20C , are selected to have an affinity for the sample fluid that is greater than the skin so that the fluid or blood in the tube is pulled up by capillary action. However, the capillary tube is also chosen to have a lower fluid or blood sampling capacity than a test strip or receiving surface of a test device so that the fluid or blood sample is drawn from the capillary tube into or onto the test strip or device. Such materials for the capillary tube may be readily determined and chosen by those skilled in the art, but generally nylon, PTFE, and the like capillary tubes will perform this function. It will be appreciated that the choice of such material for the capillary tube must be relative to the materials present in the mechanical structure of the test strip or tester when this aspect of the invention is to be used.

The double-stop return springs 49 Provide a mechanism after activation to pull the needle back out of the wound to allow an accumulation of blood 61 to enable. When the skin is pierced, pull the auxiliary springs 49 withdraw the needle from the wound and release the vibratory system of the stimulation ring 25 to force a bloodstream out of the wound. The stimulator ring can oscillate in a preferred range of 1 to 5 mm. The frequency may vary from 5 to 1000 oscillations per minute in the preferred embodiment. The vibration of the stimulator ring 25 gets off the engine 51 stimulated the stimulator ring 25 vibrated to pump the blood out of the wound into the surrounding skin capillaries so that blood will flow to the surface of the skin and eject the disposable device 72 can touch. Every downward stroke of the stimulator ring 25 causes this pumping process. The disposable device 72 is then using the auxiliary motion spring 74 , which by an auxiliary motion trigger 75 is released, lowered to the blood bead and triggered the suction of the blood. The suction device shown here 85 is a mini syringe that is powered by a spring 86 is activated when the auxiliary motion trigger 75 is released, causing blood 61 in the disposable device 72 is pulled up. The stop and adjustment 19 controls the penetration depth of the lancet 30 so that the optimum penetration depth for a particular sampling point is achieved.

12A and 12B show a minimally invasive sampling device of the present invention including a disposable lancing device, a reusable sampling device, and a disposable absorbent test strip 83 used. 12A shows the device in a side view and 12B in a front view. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical components housed in the device.

The main body consists of an elongated hollow cylindrical tube with openings at both ends. The lancing piece 30 , the part of the disposable device 33 is, can be retracted or extended, leaving it over the end of the main body 1 can protrude is positioned at one end. The clamping devices 37 protrude from the sides of the main body 1 out. The lancing piece 30 is protected by it in the tube 35 being withdrawn, the part of the disposable device 33 is. The tube 35 acts as the lancing guide and the lancet protection. The disposable device 33 gets on the main body 1 fixed so that it is positioned in the right place to guide the lancet and is from the disposable clamping device 3 kept in the normal position. The firing pin 39 is pushed forward to the lancet in the patient 41 to drive, by the spring 43 and the tensioning piston assembly 36 , The tensioning piston is in normal position by a cam 45 and a trigger 47 locked. The double-stop return spring 49 is arranged and dimensioned to the lancet 30 back in the tube 35 retrieve.

The double-stop return springs 49 Provide a mechanism after activation to pull the needle back out of the wound to allow an accumulation of blood 61 to enable. When the skin is pierced, pull the auxiliary springs 49 remove the needle from the wound and release the swing system of the stimulation ring 25 to force a bloodstream to the wound. The cam 55 puts the oscillator ring 57 in vibration, the movement on the stimulation ring 25 transfers. The stimulator ring can oscillate in the preferred range of 1 to 5 mm. The frequency may vary from 500 to 1000 cycles per minute in the preferred embodiment. The vibration of the stimulator ring 25 gets off the engine 51 stimulated. The battery 56 provides energy to the engine 51 driving the stimulator ring 25 vibrated to pump the blood from the surrounding capillaries of the skin into the wound. Every downward stroke of the stimulator ring 25 pushes the stimulator spring 53 Together, the backward movement for the stimulator ring 25 allows. The disposable chemical strip 83 is then using an auxiliary motion spring 74 that from an auxiliary motion trigger 75 is released, lowered to the bead of blood. The blood is taken from the disposable chemical strip 83 absorbed into a slot in the main body 1 and into the stimulator ring 25 fits.

The stop and adjustment devices 19 control the penetration depth of the lancet 30 so that the optimum penetration depth for a particular sampling point is achieved.

13 and 14 show an association of the inventive, minimally invasive sampling device with a chemical test measurement, z. As blood sugar, and an electronic display, a disposable lancing device 33 , a reusable sampling device 1 , a disposable absorbent test strip 83 and a method of outputting such a colorimetric test, which is displayed electronically and has an electronic display system. 13 shows the device in a side view and 14 in a front view. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical and electrical components housed in the device.

The main body 1 consists of an elongated, hollow, cylindrical tube with openings at both ends. The lancing piece 30 that part of a disposable device 33 is, can be retracted or extended so that it is over the end of the main body 1 can protrude is positioned at one end. The clamping devices 37 protrude from the sides of the main body 1 out. The lancing piece 30 is protected by it in the tube 35 being withdrawn, the part of the disposable device 33 is. The tube 35 acts as the lancing guide and the lance guard. The disposable device 33 gets on the main body 1 fixed so that it is positioned in the right place to guide the lancet, and by the disposable clamping device 3 kept in place. The firing pin 39 is pushed forward to the lancet in the patient 41 to drive, by the spring 43 and the tensioning piston assembly 36 , The tensioning piston is in normal position by a cam 45 and a trigger 47 locked. The double-stop return spring 49 is arranged and dimensioned to the lancet 30 back in the tube 35 retrieve.

The double-stop return springs 49 Provide a mechanism after activation to pull the needle back out of the wound to allow an accumulation of blood 61 to enable. When the skin is pierced, pull the auxiliary springs 49 withdraw the needle from the wound and release the vibratory system of the stimulation ring 25 to force a bloodstream to the wound. The cam 55 puts the oscillator ring 57 in vibration, the movement on the stimulation ring 25 transfers. The stimulation ring can oscillate in the preferred range of 1 to 5 mm. The frequency may vary from 5 to 1000 oscillations per minute in the preferred embodiment. The vibration of the stimulator ring 25 gets off the engine 51 stimulated. The battery 56 provides energy to the engine 51 driving the stimulator ring 25 vibrated to pump the blood from the surrounding capillaries in the skin into the wound. Every downward stroke of the stimulator ring 25 pushes the stimulator ring 53 Together, the backward movement for the stimulator ring 25 allows. The disposable chemical strip 83 is then using the auxiliary motion spring 74 that from an auxiliary motion trigger 75 is released, lowered to the blood bead and triggered the suction of the blood. The blood gets from the disposable chemical strip 83 absorbed in the disposable device 33 is incorporated. The strip is then put in place by a colorimetric system with an LED 88 output and analyzed by the electronics that is part of the device, and on a display 84 displayed.

The stop and adjustment devices 19 control the penetration depth of the lancet 30 so that the optimum penetration depth for a particular sampling point is achieved.

15 shows a combination of a minimally invasive sampling device according to the invention with a chemical test measurement, z. As blood sugar, and an electronic output, a disposable lancing device 33 , a reusable sampling device 1 , a disposable absorbent test strip 83 and a method of outputting such an electrochemical test that is output electronically and has an electronic output system. The device consists of numerous Components which are described in more detail below. The main body 1 carries various mechanical and electrical components housed in the device.

The main body 1 consists of an elongated, hollow, cylindrical tube with openings at both ends. The lancing piece 30 , the part of the disposable device 33 is, can be retracted and extended, so that it over the end of the main body 1 can protrude is positioned at one end. The clamping devices 37 protrude from the sides of the main body 1 out. The lancing piece 30 is protected by it in the tube 35 being withdrawn, the part of the disposable device 33 is. The tube 35 acts as the lancing guide and the lancet protection. The disposable device 33 gets on the main body 1 attached so that it is positioned in the correct position to guide the lancet, and is of the disposable clamping device 3 kept in place. The firing pin 39 is pushed forward to the lancet in the patient 41 to drive, by the spring 43 and the tensioning piston assembly 36 , The tensioning piston is in normal position by a cam 45 and a trigger 47 locked. The double-stop return spring 49 is arranged and dimensioned to the lancet 30 back in the tube 35 retrieve.

The double-stop return springs 49 Provide a mechanism after activation to pull the needle back out of the wound to allow an accumulation of blood 61 to enable. When the skin is pierced, pull the auxiliary springs 49 withdraw the needle from the wound and release the vibratory system of the stimulation ring 25 to force a bloodstream to the wound. The cam 55 puts the oscillator ring 57 in vibration, the movement on the stimulation ring 25 transfers. The stimulator ring can oscillate in the preferred range of 1 to 5 mm. The frequency may vary from 5 to 1000 oscillations per minute in the preferred embodiment. The vibration of the stimulator ring 25 gets off the engine 51 stimulated. The battery 56 provides energy to the engine 51 driving the stimulator ring 25 vibrated to pump the blood from the surrounding capillaries in the skin into the wound. Every downward stroke of the stimulator ring 25 pushes the stimulator spring 53 Together, the backward movement for the stimulator ring 25 allows. The disposable test strip 83 is then using the auxiliary motion spring 74 that from the auxiliary motion trigger 75 is released, lowered to the blood bead and triggered the suction of the blood. The blood is taken from the disposable chemical strip 83 absorbed in the disposable device 33 is incorporated. The strip is then read in-situ by one milliampere / millivolt detection electronics, depending on the specific chemistry of the test strip. This reading is converted into a chemical concentration by the electronics on the printed circuit board and displayed on the LCD on the side of the device.

The stop and adjustment devices 19 control the penetration depth of the lancet 30 so that the optimum penetration depth for a particular sampling point is achieved.

16 and 17 show an association of the minimally invasive sampling device with a chemical test measurement, z. B. Blood sugar, which is a disposable lancing device 33 , a reusable sampling device 1 , a disposable absorbent test strip 83 which can provide semiquantitative colorimetric results. The device consists of numerous components, which are described in more detail below. The main body 1 carries the various mechanical and electrical components housed in the device.

The main body 1 consists of an elongated, hollow, cylindrical tube with openings at both ends. The lancing piece 30 , the part of the disposable device 33 is, can be retracted or extended so that it is over the end of the main body 1 can protrude is positioned at one end. The clamping devices 37 stick out of the sides of the main body. The lancing piece 30 is protected by it in the tube 35 being withdrawn, the part of the disposable device 33 is. The tube 35 acts as the lancing guide and the lancet protection. The disposable device 33 gets on the main body 1 attached so that it is positioned in the correct location to guide the lancet and is from the disposable clamping device 3 kept in place. The firing pin 39 is pushed forward to the lancet in the patient 41 to drive, by the spring 43 and the tensioning piston assembly 36 , The tensioning piston is in normal position by a cam 45 and a trigger 47 locked. The double-stop return spring 49 is arranged and dimensioned to the lancet 30 back in the tube 35 retrieve.

The double-stop return springs 49 Provide a mechanism after activation to pull the needle back out of the wound to allow an accumulation of blood 61 to make it possible. When the skin is pierced, pull the auxiliary springs 49 The needle back out of the wound and release a vibration system of the stimulation ring 25 to force a bloodstream to the wound. The cam 55 puts the oscillator ring 57 in vibration, the movement on the stimulation ring 25 transfers. Of the Stimulator ring can swing in the preferred range of 1 to 5 mm. The frequency may vary from 20 to 200 oscillations per minute in the preferred embodiment. The vibration of the stimulator ring 25 gets off the engine 51 stimulated. The battery 56 provides energy to the engine 51 driving the stimulator ring 25 vibrated to the blood 61 from the surrounding capillaries in the skin to pump into the wound. Every downward stroke of the stimulator ring 25 pushes the stimulator spring 53 Together, the backward movement for the stimulator ring 25 allows. The disposable chemical strip 83 is then using an auxiliary motion spring 74 that from an auxiliary motion trigger 85 is released, lowered to the blood bead and triggered the suction of the blood. The blood gets from the disposable chemical strip 83 absorbed. The strip is then removed and read by the patient.

The stop and adjustment devices 19 control the penetration depth of the lancet 30 so that the optimum penetration depth for a particular sampling point is achieved.

18 shows an integrated, minimally invasive sampling device incorporating a disposable piercing, pacing and penetration depth adjuster 92 used. The device may have any of the configurations described herein as being in accordance with the invention. This modification uses the same parts used in a typical reusable sampling device, e.g. B. 11 , With 19 . 30 . 72 . 25 . 3 are designated. The disposable unit may include a test strip, a sample container, an electrical detection unit, and other test and sampling components.

19A shows the idea of an alternating double stimulation ring system. The auxiliary stimulation ring 120 changes its position by 180 ° out of phase with the stimulation ring 25 , This creates a peristaltic pumping motion on the capillaries near the root. This device can be used with any embodiment to increase blood flow. The connecting link 121 connects the two rings to the main body 1 , The peristaltic pumping causes the body fluid to be forced to the wound by massaging the fluid inwardly toward the wound.

19B shows the idea of a concentric collapsible stimulation ring. In this embodiment, the inner ring touches 25 the skin after the outer ring 120 , A feather 299 provides a resistance and such a process that the outer ring 120 the skin in front of the inner ring 25 touched. This forces the body fluid to the wound by massaging the fluid inside the wound.

In an alternative embodiment, the ring 25 also act as a sample pick-up tube after the piercing needle 16 has been withdrawn.

Zn another alternative embodiment, compressed gas pulses in annular spaces between the housing 1 and the ring 120 and / or between the ring 120 and the ring 25 are delivered to massage the skin and to stimulate a flow of current. Such use of compressed gas pulses may instead or in combination with the movement of the ring 120 or other stimulation parts.

20A shows a bell-shaped capillary tube 150 which is used to take a body fluid sample. The bell-shaped capillary tube is shaped to fit around the drop, and this is pulled up the tube until it reaches the balloon or ball 151 reached. This helps to ensure that a reasonable sample 152 is pulled and the balloon 151 the capillary action interrupts. The sample 152 is by squeezing the balloon 151 issued. The capillary can be heated to increase the capillary pulling and the speed of sampling.

20B and 20C show an alternative method in which the sample 152 in the tube 15C Pulled upwards and then the tube is inverted so that the sample on an absorbent Prüfbausch 153 can be transferred.

20D shows a straight capillary 310 in which the sample 152 in the tube 310 Pulled upwards and by the capillary action of the Prüfbauschs on the absorbent Prüfbausch 153 is transmitted.

The tubes in 20A . 20B . 20C and 20D can be modified with a surfactant to increase the absorption capacity of the body fluid.

21 shows a device in which the vibrating ring 130 at the disposable clamping device 3 is attached to the needle 33 to vibrate to stimulate the wound and keep it open so that it does not close. In addition, a heated ring 135 used to increase the capillary volume to stimulate the bloodstream.

22A shows a multiple needle piercing device used to cause several wounds increase the sample size. The multiple needles are of sufficient size and length to minimize the sensation of pain and still produce a corresponding sample size.

22B shows a broader single lancet that is used to cause multiple wounds to increase the sample size.

22C and 22D show a stamped platelet having a number of small barbs formed therein and used to cause multiple wounds to increase the sample size. The multiple barbs are of sufficient size and length to minimize the sensation of pain and still produce a corresponding sample size.

The lancing devices in 22A to 22D may be used in the sampling devices disclosed herein.

Claims (41)

Apparatus for obtaining a body fluid sample through the skin, with: a housing part that can be used and is adapted to receive a needle for piercing the skin; one Spring part in the housing to drive the needle out of the end of the housing sufficiently far, to penetrate the skin; a piston part for retraction the needle against the spring tension and a trigger part to with the piston to engage to hold the needle withdrawn until it stops from the trigger is released; a stop member to the needle penetration depth limit the skin when released from the trigger; one Sample container which is in communication with the needle for picking up the sample the needle; and a second spring for retracting the needle from the Skin a suction cam and piston that activates when retracting the needle Be sure to pull the fluid sample that is on the surface of the skin accumulates in the sample container. Apparatus according to claim 1, comprising: a skin stimulation part to touch and massaging the skin; a vibrating system to vibrate the skin stimulation part; and a spring and actuator part, this is to activate the vibrating system after the needle has been withdrawn from the skin suitable is. Apparatus according to claim 2, comprising: an actuator, around the stimulation part before a needle penetration of the skin into to extend the lower position, to keep the skin tight and to execution a precise needle penetration depth control. Apparatus according to claim 1, 2 or 3, comprising: one Actuator system for cyclic movement of the needle in the vertical or horizontal direction, while the needle is inserted into the skin. Device for obtaining a body fluid sample through the skin, With: a housing part, suitable for receiving a needle for puncturing the skin; one Drive device in the housing to drive the needle sufficiently out of the end of the housing, to penetrate the skin; a stop member to the needle penetration depth limit the skin by the drive device; a sample container, the communicating with the needle, for receiving the sample from the Needle; a device for retracting the needle from the Skin; and a device for drawing the fluid sample, the yourself on the surface the skin accumulates, after Nadelrückzug in the sample container. The device of claim 5, further comprising: one Skin stimulation part to touch and massaging the skin at the needle entry site; a vibration system for vibrating the skin stimulation part; and a spring and actuator part, this is to activate the vibrating system after the needle has been withdrawn from the skin suitable is. Device according to claim 6, further comprising a spring and actuating element part, this is to activate the vibrating system after the needle has been withdrawn from the skin suitable is. Device for obtaining a body fluid sample through the skin, With: a housing part, which is usable and suitable in the hand, a part or System for piercing the skin; a sample collection tube, the is positioned to collect a fluid sample from the pierced Skin exits an actuator to cause that part or system punctures the skin; and a pumping system for Pull the fluid sample into the tube. The device of claim 8, wherein the skin puncturing system comprises a laser system or fluid under pressure which is directed to pierce the skin. Apparatus according to claim 8, wherein said part is for Piercing the skin of a needle that is adjacent to the ground Tube positioned is, and a driving part for driving the needle into the skin, and a second part to retreat the needle from the skin. The device of claim 10, wherein the tube has a Multi-chamber tube which has a needle in a chamber and for receiving a sample in a second chamber is suitable. Device for taking a body fluid sample from a wound in the skin, with: a housing part with a longitudinal axis, which is usable and a chamber for collecting a fluid sample which emerges from the wound; and a skin stimulation part, concentric in the housing around its longitudinal axis at the end of the housing part is movably positioned to touch and massage the skin near the wound, around the fluid flow to and from the wound to stimulate. The device of claim 12, wherein the stimulation part between the chamber and the housing positioned and adapted to extend telescopically out of the housing, to touch the skin and the body fluid to pump to the wound. The device of claim 13, wherein the stimulation part suitable is the opening to enlarge the wound and to increase the fluid flow from the wound. The device of claim 13, wherein the stimulation part is suitable to sweep the skin towards the wound to the fluid flow to increase from the wound. Apparatus according to claim 2, 6 or 12, wherein said Stimulation part has: a polygonal, square, circular or annular Mold, a kneading arm or squeeze roller, a system for use a fluid under pressure to contact and stimulate the skin, or a fluid contained in a flexible membrane for contacting and Simulate the skin. Needle for piercing the skin, with a hollow Tube with a pointed spur projection extending substantially longitudinally from a portion of one side of the end of the tube extends. The needle of claim 17, wherein the spur portion to the center line of the tube is angled. Needle with an angled or oblique tip for piercing the skin, with a hollow tube, the longitudinal passage in the tube eccentric in the tube is arranged. The device for use in a body fluid sampling device to obtain a sample through the skin, with: a spacer, that to touch the skin is suitable; a sample collection tube contained in the spacer part is positioned to receive the fluid sample; a pumping system for drawing the fluid sample into the collection tube; a lancet part which is movably positioned in the spacer part adjacent to the tube is to pierce the skin; and Electrodes in the spacer part positioned and suitable for connection to a sensor, to detect the presence of fluid in the spacer part. Apparatus according to claim 20, further comprising electrodes, in the collection tube are positioned to connect to a sensor to detect the presence and to detect the amount of fluid in the collection tube. Apparatus according to claim 1, 5, 8, 12, 18 or 20, furthermore with: an integrated test unit for testing the Sample. Apparatus according to claim 22, wherein the test unit a colorimetric test unit or an electrochemical test unit having. Apparatus according to claim 1, 5, 8, 12 or 20, which is suitable, a Prüfvorrichtungseinheit which absorbs the sample from the place of the dignity. Body fluid collection device with a capillary tube, which at one end to touch the skin is widened and at the opposite end a suction part having. Apparatus according to claim 25, further comprising a test strip, on which the fluid sample from the capillary tube is applied. Apparatus according to claim 2, 6 or 12, wherein said Stimulation part or system a flat spiral spring, ultrasonic effect, piezoelectric effect, heating, Having friction or vibration. Apparatus according to claim 4, wherein the actuator system Ultrasonic, piezoelectric, mechanical or electrical effect having. Apparatus according to claim 1, 5, 8, 12 or 20, further comprising a system for injecting a material into the skin. Apparatus according to claim 1, 5, 12 or 20, further with a suction device for drawing a sample into the needle, tube or Chamber. Apparatus according to claim 1, 5, 8, 20 or 24, wherein the needle, the system for piercing the skin or the lancing part is suitable to puncture the skin at an angle smaller than 90 °. Device according to claim 31, which is suitable the skin before or during of piercing. Apparatus according to claim 1, 5, 8, 12 or 20, wherein the section of the device that pierces the skin, and the section of the device collecting or containing the sample disposable units are. Apparatus according to claim 1, 5, 8, 12 or 20, wherein the portion of the device piercing the skin is suitable is to swing while he introduced into the skin is, with the swing by vertical, horizontal, rotary or cyclic movement takes place. Apparatus according to claim 1, 5, 8, 12 or 20, further with a system for applying an electrical potential across the Skin from a point away from the wound in the skin, to the point near or in the wound in the skin. Apparatus according to claim 1, 5, 8, 12 or 20, comprising a system to measure the volume of the collected sample. Apparatus according to claim 36, wherein the measuring system is suitable, the sample collection at a predetermined sample volume to end. Apparatus according to claim 1, 5, 8, 12, 20 or 25, the sample container or the sample collection tube comprising: a material having a suction capacity of the sample fluid that is sufficiently high However, to exclude the fluid sample from the surface of the skin is also sufficiently small to remove the fluid sample from the container or the tube when it comes into contact with a test strip or a tester is arranged, whose or the absorption capacity for the fluid sample is higher as that of the container or the tube. A method of collecting a body fluid sample comprising the steps of: piercing the skin with a subcutaneous needle; Retracting the needle from the Skin; Massaging an area adjacent to the wound; and take up of the fluid sample in front of the surface the skin into the subcutaneous needle. A method of collecting a body fluid sample comprising the steps of: mechanical Massaging a skin area; Piercing the skin, around one Create wound; mechanical massaging of a skin area adjacent to the wound; and Picking up a fluid sample the wound or the surface of the skin. The method of claim 40, comprising the step of: inserting Device to pierce the skin, and swinging the Device in the wound.